WO2002011795A1 - Dispositif et procede permettant de doser des substances - Google Patents

Dispositif et procede permettant de doser des substances Download PDF

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Publication number
WO2002011795A1
WO2002011795A1 PCT/CH2001/000470 CH0100470W WO0211795A1 WO 2002011795 A1 WO2002011795 A1 WO 2002011795A1 CH 0100470 W CH0100470 W CH 0100470W WO 0211795 A1 WO0211795 A1 WO 0211795A1
Authority
WO
WIPO (PCT)
Prior art keywords
signals
output
signal
dispensed
setting
Prior art date
Application number
PCT/CH2001/000470
Other languages
German (de)
English (en)
Inventor
Bruno Maire
Original Assignee
Disetronic Licensing Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Disetronic Licensing Ag filed Critical Disetronic Licensing Ag
Priority to AU2001272294A priority Critical patent/AU2001272294A1/en
Publication of WO2002011795A1 publication Critical patent/WO2002011795A1/fr
Priority to US10/360,190 priority patent/US7201741B2/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/31556Accuracy improving means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31535Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/3155Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31553Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe without axial movement of dose setting member
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01DMEASURING NOT SPECIALLY ADAPTED FOR A SPECIFIC VARIABLE; ARRANGEMENTS FOR MEASURING TWO OR MORE VARIABLES NOT COVERED IN A SINGLE OTHER SUBCLASS; TARIFF METERING APPARATUS; MEASURING OR TESTING NOT OTHERWISE PROVIDED FOR
    • G01D7/00Indicating measured values
    • G01D7/12Audible indication of meter readings, e.g. for the blind
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3125Details specific display means, e.g. to indicate dose setting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581Means for facilitating use, e.g. by people with impaired vision by audible feedback

Definitions

  • the present invention relates to a device and a method for dosing substances to be dispensed, in particular liquids, which must be reliably carried out, for example, in the injection of liquids containing insulin in diabetics.
  • a display device for a medical injection device is known from EP 0 581 925 B1, wherein the amount of an injection dose to be injected can be set by means of a rotatable control button and the number of defined partial rotations of the control button is shown on an LCD display.
  • DE 19820316A1 discloses a processor-controlled hand-held device for receiving conventional injection syringes and ampoules with an acoustic display device for set and dispensed quantity parameters, this set quantity being output as speech or signal only after a specific quantity has been set.
  • thermometers for the visually impaired and blind are known which acoustically output a measured temperature at the end of a measuring process.
  • the device according to the invention for dosing substances to be dispensed, in particular liquids, such as is necessary for diabetics when injecting insulin and must be carried out with great reliability has an adjusting device, such as a rotary knob, with which the amount of the substance to be dispensed is determined can be adjusted.
  • a signal recording device is provided with which setting signals on the setting device can be recorded.
  • this can be an incremental encoder which, for example, outputs a signal for each partial rotation of the rotary knob that is preferably between 1 ° and 180 °. It is also possible to provide a “+” and a “-” button, the operating time of the respective buttons being recorded as setting signals, for example.
  • the signal recording device outputs the set signal (s) to an evaluation unit, which determines a set dose or amount of the substance to be delivered from these set signals. Depending on this determined dose, a control signal is output to a speech synthesizer, which outputs a speech signal that relates to the determined dose.
  • This speech signal is transmitted to a speech output device, such as a loudspeaker or a hearing aid, so that a user of the device according to the invention can hear what dose he has currently set. This process is preferably carried out continuously, so that voice output can be continuous or interrupted by short intervals already during the setting process.
  • a rotary knob is preferably provided as the adjusting device, the amount of a substance to be dispensed being determined by the angle of rotation or the number of partial rotations of the rotary knob.
  • the angle of rotation can be multiplied by a predetermined constant to determine the units to be output per unit of angle.
  • a locking device can be provided, for example, which causes the rotary knob to be heard and / or felt after a completed rotary movement.
  • the locking devices can be provided, for example, in such a way that locking takes place after a certain partial rotation, such as a quarter or half turn, in order to enable a desired fine adjustment.
  • the rotary knob After locking, however, the rotary knob should be able to be turned further without greater force, so that the locking of the rotary knob can be felt or heard, but does not constitute an obstacle to the setting.
  • a continuously rotatable, non-latching turret can also be used.
  • the rotary knob is preferably designed such that a rotary movement of the knob is converted into an axial movement, which can be implemented, for example, by using a screw mechanism. So over the stroke of the knob z. B. a substance to be dispensed can be dosed directly, which is dispensed or injected after dosing, for example by means of a pressure force on the rotary knob. According to the invention, in such a configuration of the metering device, the set quantity is preferably output as a speech signal during and / or at the end of a setting process.
  • the rotary knob can also be designed so that it is not axially displaced substantially when rotating, so that, for. B. only the rotation corresponding signals are attacked, which are used to control a metering device such. B. an electric motor can be used. This eliminates a screwing back of the knob when z. B. a new ampoule is inserted.
  • an incremental encoder is provided on the rotary knob as a signal recording device, which, for example, generates a signal, for example, for each (partial) rotary movement carried out at a predeterminable angle.
  • B. emits a pulse signal and uses this signal to drive a stepper motor, for example, with which the amount of a substance to be dispensed can be determined.
  • the signals emitted by the increment encoder can also be sent directly to the evaluation unit for conversion into a speech signal.
  • the above-mentioned embodiments of the invention can be designed such that, for example, in the basic state there is a certain adjustable offset which corresponds, for example, to the usual or average amount of the substance to be dispensed.
  • This offset can either be set by the user, for example by the setting device itself, which can take place in a specific operating mode, which, for. B. can be selected by pressing the adjusting device, or by an additional z.
  • a user it is also possible for a user to use a different type, e.g. B. stores an interface from a PC.
  • an offset for example, the user then only having to modify the specified amount depending on the desired application.
  • the use of an offset has the advantage that a user no longer has to make any adjustments if one average quantity of, for example, 24 units is dispensed. If before a larger meal e.g. For example, if a larger quantity of, for example, 28 units is to be dispensed, only adjustment movements for four units have to be carried out, so that, for example, up to 28 units are not counted during the adjustment process, which represents a considerable simplification and increase in user-friendliness.
  • the set quantity is output as speech
  • the use of an offset for the quantity to be dispensed cannot lead to incorrect settings
  • the quantity set as offset can also be output as a speech output, for example “twenty-four”, during a setting process, with each change of the basic quantity predetermined by an offset can also be output as a speech signal, such as a continuous counting of, for example, "twenty-five, twenty-six " during the actuation of the setting device.
  • An actuating device is preferably provided, with which the device according to the invention, for. B. can be communicated that the values or signals output via the voice output device have been understood by the user and substance delivery is to be prepared or carried out, or that an operating mode is changed.
  • a button or a microphone can be provided as the actuating device, for example, into which a defined speech signal, such as “understand”, can be spoken, so that, for example, repeated speech output of a set amount is interrupted and, for example, the delivery of the set amount is released
  • a rotary knob can be pressed when the setting has been completed.
  • a device for outputting an alarm or warning signal is preferably provided, which can also be integrated in the evaluation unit in order to output a warning signal to a user when unusual quantities, such as an extremely low or excessively large dose, are set.
  • the warning signal can Example of a voice output, which gives the user a general warning message, such as "Warning! Check set quantity! ", Or be a specific voice output depending on the detected unusual setting, such as” Set quantity too large! ".
  • Optical or tactile or tactile warning signals can also be output if unusual setting states are detected. Combinations of different warning signals to indicate quantities that are probably incorrectly set are also possible.
  • the dosing device according to the invention can also be designed in such a way that certain limits of the maximum quantity to be dispensed can be set, which, if the device is operated incorrectly, ensure that no dangerous doses can be dispensed.
  • the speech output device can also be designed such that speech that is not immediately audible is output, as is the case, for example, with a loudspeaker, but rather that corresponding signals are emitted by the device according to the invention, which are only converted into audible speech signals by another device.
  • a connection for a plug-in earphone or a coupling for a hearing aid can be provided, the signals output being able to be transmitted to the hearing aid by radio, for example. It is therefore not necessary for there to be a physical connection between the metering device and the hearing aid, which considerably simplifies the setting.
  • one or more output devices are preferably provided, such as an optical display, a device that emits a tactile signal, such as a vibration element, or an interface, which contains information about the set amount, the time of delivery a substance or similar values.
  • a log of the dispensed quantities with the associated times of day can be output to an external device in order, for example, to store corresponding information in an electronic diary of the user of the device according to the invention, so that, for example, a doctor can get an overview of injected insulin quantities ,
  • data it is possible for data to be entered into the device according to the invention via an interface provided on the dosing device, for example in order to store an average value as an offset for setting the average quantity to be dispensed or to program the speech output device into a desired language or into desired speech output signals protest arrivedn.
  • the metering device can advantageously be configured such that a set quantity is output multiple times as a voice signal, so that, for example, with a setting of 24 units, the word “twenty-four” is output three times if, for example, after a set period of time there is no change by the setting device is ascertained before the voice output is switched off, and the voice output can be reactivated immediately if a setting operation by the user is detected.
  • the user can be informed that this end value is for dosing the substance to be dispensed has been permanently set and has not been inadvertently changed by an undesired actuation of the setting device, it is also possible to configure the dosing device in such a way that, for example, depending on a set operating mode, further for the n Users can be given interesting parameters, such as Example, the remaining amount of the substance to be dispensed in the dosing device, the total amount dispensed so far, the dosing of the last dispensed amount, the operating status, such as error messages in certain parts, the display that only a little substance to be dispensed is available in the dosing device or the like , for this purpose, suitable selection devices for setting the operating mode, such as operating buttons or voice input systems, can be provided.
  • the method according to the invention for dosing substances to be dispensed has the following steps:
  • the actuation or change of an adjusting device for dosing the substance to be dispensed is recorded, with information about the set quantity preferably being output continuously as a voice output as a function of this recorded signal.
  • a voice output takes place during the entire setting process, for example continuously or in short time intervals of z. B. 1 to 5 seconds the number of set units to be dispensed is output, or with every change in the set quantity to be dispensed, there is a voice output so that a continuous counting of the set quantity is audible for the user.
  • This configuration is of great advantage for a user, since he is continuously informed about the set amount during an adjustment process, that is to say, during an adjustment process, for example, by turning an adjustment button, it cannot count with respect to the rotary movements carried out.
  • the setting can thus be done interactively and z. B. can be ended by pressing the rotary knob.
  • Warning signals and / or operating instructions are preferably output to the user, which does not necessarily have to take place during a setting process in order to inform the user about certain operating states, such as the need to recharge a battery, a new ampoule in the Insert the dosing device, check the set amount again, as this appears unusual or the user is informed that a new injection must be carried out within the next time.
  • all desired operating states or usage information can be output to the user as voice output.
  • FIG. 1 shows an exemplary embodiment of the device according to the invention
  • FIG. 2 shows a flow chart to illustrate the process according to the invention
  • FIG. 1 shows a device according to the invention for metering substances to be dispensed, in particular liquids, only the rear part of a so-called pen pump 10 being shown for simplification.
  • the invention can be used with any pumps, so-called pens, or any other devices in which a substance to be dispensed, which can also be a cream or a gel, for example, is to be dosed as precisely as possible.
  • a rotary knob 1 is provided, which has grooves 1a distributed over its circumference at the same distance in the axial direction. These grooves la can latch with latching devices 1b distributed around the circumference of the rotary knob 1 and rest against the circumference of the rotary knob 1, a latching device 1b latching in a groove la, such as an elastic element, being released again by a force that can be metered as little as possible can.
  • a signal recording device 2 is, for example, an incremental encoder and outputs a signal to an integrated circuit 3 when a groove la passes.
  • the rotary knob 1 can also encodings be provided on the rotary knob 1, which enable the rotary movement and direction of rotation of the rotary knob 1 to be recorded as continuously as possible.
  • the rotary knob 1 is not designed as a screw rotary knob, so that it does not move in the axial direction when a rotary movement takes place.
  • a rotary knob 1 which can be screwed in or out in order to act, for example, directly on an ampoule with a substance to be dispensed.
  • the signals detected by the increment encoders 2 shown in FIG. 1 with regard to the setting position of the rotary knob 1 are evaluated in the integrated circuit 3 and converted into voice signals which are output via a connected loudspeaker 4 in order to output acoustic or voice signals to a user with regard to the set amount , Furthermore, the information relating to the set amount is output via a signal line 5 immediately or only after the setting process has ended to a stepping motor or another suitable metering device which provides the amount of the substance to be dispensed.
  • the substance to be dispensed can be pumped, for example, from a storage container, such as an ampoule, into an injection space, from which the substance is released to the outside during an injection.
  • the metering of substances to be dispensed by means of suitable devices is known in the prior art and is therefore not described in more detail here.
  • FIG. 2 shows a flow chart of the method according to the invention for metering substances to be dispensed, the rotary movement of the metering button 1 being recorded in a first step in the embodiment shown in FIG.
  • the detected rotary movement is converted into predetermined units, which can be shown on a 7-segment display, for example, as is known in the prior art.
  • the value “24” is shown by way of example in FIG. 2.
  • the setting signals are converted into speech signals by means of a suitable speech synthesis and output as speech, such as the output of the word “twenty-four” as shown in FIG. 2.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne un dispositif permettant de doser des substances devant être administrées, notamment des liquides, qui sont en particulier destinés à être injectés. Ce dispositif comprend un dispositif de réglage, qui sert à régler la quantité de substance à administrer, un dispositif de réception de signal, qui sert à collecter des signaux de réglage issus dudit dispositif de réglage, une unité d'évaluation, qui sert à détecter et à évaluer les signaux de réglage détectés par le dispositif de réception de signal, un dispositif qui sert à produire des signaux vocaux, en fonction des signaux d'évaluation issus de l'unité d'évaluation, ainsi qu'un dispositif qui sert à émettre des signaux vocaux. La présente invention concerne également un procédé permettant de doser des substances devant être administrées, notamment des liquides. Ce procédé consiste à détecter un signal de réglage issu d'un dispositif de réglage, puis à émettre un signal vocal, en fonction du signal de réglage détecté.
PCT/CH2001/000470 2000-08-09 2001-07-31 Dispositif et procede permettant de doser des substances WO2002011795A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2001272294A AU2001272294A1 (en) 2000-08-09 2001-07-31 Device and method for dosing substances
US10/360,190 US7201741B2 (en) 2000-08-09 2003-02-07 Device and method for dosing substances

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10038936.8 2000-08-09
DE10038936A DE10038936B4 (de) 2000-08-09 2000-08-09 Vorrichtung zur Dosierung von Substanzen mit kontinuierlicher Sprachausgabe

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US10/360,190 Continuation US7201741B2 (en) 2000-08-09 2003-02-07 Device and method for dosing substances

Publications (1)

Publication Number Publication Date
WO2002011795A1 true WO2002011795A1 (fr) 2002-02-14

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PCT/CH2001/000470 WO2002011795A1 (fr) 2000-08-09 2001-07-31 Dispositif et procede permettant de doser des substances

Country Status (4)

Country Link
US (1) US7201741B2 (fr)
AU (1) AU2001272294A1 (fr)
DE (1) DE10038936B4 (fr)
WO (1) WO2002011795A1 (fr)

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US8206360B2 (en) 2005-02-01 2012-06-26 Intelliject, Inc. Devices, systems and methods for medicament delivery
US9022980B2 (en) 2005-02-01 2015-05-05 Kaleo, Inc. Medical injector simulation device
US8231573B2 (en) 2005-02-01 2012-07-31 Intelliject, Inc. Medicament delivery device having an electronic circuit system
US8361026B2 (en) 2005-02-01 2013-01-29 Intelliject, Inc. Apparatus and methods for self-administration of vaccines and other medicaments
CA2976873C (fr) * 2005-02-01 2020-04-07 Kaleo, Inc. Dispositifs, systemes et procedes pour administrer un medicament
EP1893256B1 (fr) * 2005-06-16 2012-09-26 Novo Nordisk A/S Procede et appareil d'aide a des patients pour l'auto-administration de medicaments
AU2011218649B8 (en) * 2006-03-29 2015-11-19 Kaleo, Inc. Devices, systems and methods for medicament delivery
WO2008091838A2 (fr) 2007-01-22 2008-07-31 Intelliject, Inc. Injecteur médical équipé d'un système de détection et de surveillance de l'observance
USD994111S1 (en) 2008-05-12 2023-08-01 Kaleo, Inc. Medicament delivery device cover
US8021344B2 (en) 2008-07-28 2011-09-20 Intelliject, Inc. Medicament delivery device configured to produce an audible output
US20130123685A1 (en) * 2009-06-03 2013-05-16 Novo Nordisk A/S Electronically monitored injection device
WO2011144675A1 (fr) 2010-05-19 2011-11-24 Sanofi-Aventis Deutschland Gmbh Modification de données opérationnelles d'un processus de détermination d'interactions et / ou d'instructions
AU2013370241B2 (en) 2012-12-27 2018-02-15 Kaleo, Inc. Devices, systems and methods for locating and interacting with medicament delivery systems
EP3736003A1 (fr) 2013-05-07 2020-11-11 Sanofi-Aventis Deutschland GmbH Dispositif d'injection
JP2016528013A (ja) 2013-08-19 2016-09-15 ドクター レディズ ラボラトリーズ リミテッド 選択可能な単一用量の自己注射器ならびにその作製および使用方法
CN108201647A (zh) * 2016-12-19 2018-06-26 广东东阳光药业有限公司 注射器用数据采集方法及自动采集刻度数据的注射器
EP3570906A4 (fr) 2017-01-17 2020-10-21 Kaleo, Inc. Dispositifs d'administration de médicament à connectivité sans fil et à détection d'événement
US11929160B2 (en) 2018-07-16 2024-03-12 Kaleo, Inc. Medicament delivery devices with wireless connectivity and compliance detection
CN109498907A (zh) * 2018-11-20 2019-03-22 常州市第二人民医院 一种胰岛素注射笔自动报数装置

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DE29901739U1 (de) 1999-01-26 1999-09-30 Hermsen, Hans-Joachim, 32257 Bünde Sprechendes Fieberthermometer für Sehbehinderte und Blinde

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2428238A1 (fr) * 2010-07-21 2012-03-14 Samsung Electronics Co., Ltd. Procédé et appareil de mesure de dose dans un injecteur
US9526842B2 (en) 2010-07-21 2016-12-27 Samsung Electronics Co., Ltd Apparatus and method for measuring dose in injector

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US20030130853A1 (en) 2003-07-10
US7201741B2 (en) 2007-04-10
AU2001272294A1 (en) 2002-02-18
DE10038936B4 (de) 2009-02-05
DE10038936A1 (de) 2002-02-28

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